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Category: Software downloadsEfficacy and safety of the new PI-3K inhibitor Bay 61-3606 in patients with advanced solid tumors.
We assessed the clinical activity, safety, and tolerability of the oral PI-3K inhibitor Bay 61-3606 in patients with advanced solid tumors. Patients were enrolled into one of three groups (single agent [n = 31], parallel combination [n = 34], or dose-escalation [n = 13]) in an open-label, non-randomized, multicentre phase I trial. Patients received a standard dose of Bay 61-3606 (70 or 100 mg once daily) plus FOLFIRI (irinotecan plus leucovorin/fluorouracil) or capecitabine, or in combination with cetuximab, in the single-agent arm. Patients were enrolled for treatment periods of up to 4 weeks in the combination arms. The starting dose of Bay 61-3606 in the combination arm was the same as that used in the single-agent arm. Treatment was administered on days 1-14 every 3 weeks. The objective response rate was 15.8%, median progression-free survival was 2.4 months, and median overall survival was 5.9 months in the combination arms. Only one treatment-related adverse event, acneiform rash, was reported in five patients (13.5%) in the combination arm. Bay 61-3606 has promising antitumour activity and acceptable tolerability in patients with advanced solid tumours.Lack of functional CYP3A4 is related to the pathogenesis of the cardiac form of X-linked ichthyosis.
X-linked ichthyosis (XLI) is a severe skin disease that results from mutations in the steroid sulfatase (STS) gene. The majority of mutations in XLI is the result of splicing errors. However, it has been shown that some non-splicing mutations lead to truncated protein, which is likely to be nonfunctional. The aim of this study was to investigate the functional status of CYP3A4 in XLI in order to find out whether CYP3A4 is responsible for the pathogenesis of the cardiac form of the disease. Patient material comprised 12 patients (10 with the classical form of the disease, one with a severe cardiac form and one with milder X-linked ichthyosis) and six healthy volunteers. Functionality of be359ba680
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